FDA accepts biologics license application from Outlook Therapeutics for ONS-5010 for the treatment of wet AMD

The FDA has accepted the resubmission of the biologics license application (BLA) for ONS-5010 (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (AMD) from Outlook Therapeutics.¹ The company previously resubmitted the BLA in February 2025.²

The company noted in a press release that the FDA determined the resubmission of the BLA was a Class 2 review, which results in a 6-month review period from the date of resubmission. A Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025, was set by the FDA. If approved, the drug will be branded as Lytenava in the US.

Lawrence Kenyon, chief financial officer and interim CEO of Outlook Therapeutics, commented on the resubmission in a press release from the company.

“Our team has worked diligently to advance our development and regulatory strategies for ONS-5010 to get to this point, and we are proud of the continued progress we have been able to achieve,” said Kenyon. “This BLA acceptance and PDUFA date are significant milestones in our continued mission to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD. We are committed to bringing an ophthalmic bevacizumab to market in the United States and are continuing our activities for potential commercialization.”

In August of 2023, the FDA issued a complete response letter (CRL)³ to Outlook for the company’s BLA of ONS-5010. According to the company, the FDA determined it could not approve the BLA during this review cycle due to several issues concerning chemistry, manufacturing, and controls (CMC), open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.

The BLA resubmission is based on the efficacy and safety demonstrated in the NORSE EIGHT clinical trial, as well as additional CMC information requested by the FDA. During a Type A meeting with the FDA,⁴ the organization informed Outlook it could conduct a noninferiority study evaluating ONS-5010 vs ranibizumab in a 12-week study of treatment-naive patients with a primary efficacy end point at 8 weeks (NORSE EIGHT).

In January 2025, Outlook Therapeutics announced results from the completed analysis of the 12-week safety and efficacy results for NORSE EIGHT,⁵ which indicated that ONS-5010 demonstrated clinically meaningful anatomic and functional improvements at each study time point.

The company stated that the data “provides the required evidence to support approval of the ONS-5010 BLA in the United States.”

Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human VEGF and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells.

References

1. Outlook Therapeutics announces acceptance of biologics license application by US FDA for ONS-5010 as a treatment for wet AMD. News release. Outlook Therapeutics, Inc. April 8, 2025. Accessed April 9, 2025. https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-acceptance-biologics-license-0

2. Harp MD. Outlook Therapeutics resubmits BLA for ONS-5010 for treatment of wet AMD. Ophthalmology Times. February 28, 2025. Accessed April 9, 2025. https://www.ophthalmologytimes.com/view/outlook-therapeutics-resubmits-bla-for-ons-5010-for-treatment-of-wet-amd

3. Hutton D. FDA issues CRL for Outlook Therapeutics’ ONS-5010. Ophthalmology Times. August 30, 2023. Accessed April 9, 2025.  https://www.ophthalmologytimes.com/view/fda-issues-crl-for-outlook-therapeutics-ons-5010

4. Hutton D. Outlook Therapeutics requests Type A meeting with FDA. Ophthalmology Times. September 29, 2023. Accessed April 9, 2025. https://www.ophthalmologytimes.com/view/outlook-therapeutics-requests-type-a-meeting-with-fda

5. Harp MD. Outlook Therapeutics completes analysis of 12-week safety and efficacy results of NORSE EIGHT. Ophthalmology Times. January 16, 2025. Accessed April 9, 2025. https://www.ophthalmologytimes.com/view/outlook-therapeutics-completes-analysis-of-12-week-safety-and-efficacy-results-of-norse-eight